An interventional study of Internet-based cognitive behavioral therapy and Synchronous cognitive behavioral therapy in Gambling Disorder, sponsored by Aarhus University Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by Aarhus University Hospital · Not applicable, Interventional, and Treatment
The aim of this two-armed, randomized controlled trial is to determine if internet-based cognitive behavioural therapy (CBT) is as effective as synchronous CBT (sCBT) for treating Gambling Disorder (GD) in adults. The main question it aims to answer is: Is the effect of the internet-based CBT ("SpilleFri") non-inferior to that of synchronous CBT in reducing gambling severity?
The trial will enroll 150 patients with Gambling Disorder who will be randomized (1:1) to either the experimental condition (12 weeks' treatment with the internet-based treatment "SpilleFri") or the active control condition (18 weeks individual sCBT). The primary outcome measure will be based on self-reported GD severity (NODS).
The trial will be considered effective if SpilleFri is not clinically inferior (within a predefined non-inferiority margin) to sCBT in reducing GD severity at the primary endpoint three months after end-of-treatment.
In addition to evaluating the effectiveness of the treatments, the study will conduct an exploratory analysis of the impact of each condition on secondary outcomes (changes in gambling behavior, relationship quality, and symptoms of anxiety, depression, and emotional distress). Similarly, an exploratory analysis of process variables (gambling-related self-efficacy, maladaptive gambling cognitions, emotion regulation difficulties, and gambling urge) will be conducted across conditions and clinical subgroups.
Participants will:
PROJECT GROUP: Anna Westh Stenbro (Psychologist, MSc.); Lisbeth Frostholm (Professor, Psychologist, MSc., Ph.D.); David Hodgins (Professor, Psychologist, MSc., Ph.D.)
The trial will be conducted by the research group at the Research Clinic for Gambling Disorder, based at Aarhus University Hospital, Denmark. The clinic was established in 2007 and offers assessment and specialized treatment to patients with GD.
MEASUREMENTS:
Self-reported data from the participants are collected at seven time points: At baseline (T1), randomisation (T2), three time points mid-treatment (T3, T4, T5), end-of-treatment (T6) and at 3-month follow-up (T7, primary endpoint). Due to different treatment durations in the two arms, an additional measurement point (T7b) is added to control for the effect of time for participants in the SF group, at the time point when participants in the sCBT group complete the 3-month follow-up (week 30). At T6, all participants will be invited to participate in a 12-month follow-up study (T8).
During treatment, therapists register the length, and themes, of phone conversations and face-to-face sessions in SpilleFri and equally the length and overall themes of sessions in the sCBT arm. In both arms, therapists register involvement of concerned significant others in treatment sessions. In the sCBT arm, therapist register manual fidelity and covered intervention topics after each session. Deviations are described. At the end of the treatment course, the therapists evaluate participant engagement and treatment effect (CGI-I).
For a detailed list of the measures and measurement time points included, see the section "Outcome measures".
RANDOMIZATION:
Included patients will be randomized to SF or sCBT in a 1:1 ratio. Randomization takes place immediately following the inclusion conference. A member of the research group will perform the randomization using the randomization module in the online data collection program, REDCap. When the randomization module is activated, REDCap automatically and randomly assigns participants to one of the predefined study groups in randomization blocks randomly ranging between 8 and 12. All research group members and clinicians are blinded to the current randomization block size.
POWER CALCULATION:
Sample size estimation was done using simulation of mixed linear models in Stata version 17. The relative effects of SF and sCBT will be analysed using a pre-set non-inferiority margin, determining the margin within which SF can be less effective than sCBT without being declared clinically inferior to the standard treatment. Within this margin, any difference in effect will represent a clinically unimportant loss of effect.
Simulation parameters were informed by 1) previous clinical data from the RCGD on reduction in NODS for patients given sCBT and 2) reduction in NODS for patients in the SF feasibility study. Assuming baseline-EOT-FU trajectory in NODS-score of 7-1-1 in individual CBT condition and 7-2-2 in SF condition, power of .80 was reached for 100 patients (50 in each condition). To account for dropout and attrition, a sample size of 150 is ideal.
ANALYSIS:
The hypothesized non-inferiority of SF compared to individual CBT as measured by NODS will be analysed using 2-level mixed linear models with random intercept - i.e., repeated measures nested within patients. REML estimation will be employed. Model-predicted mean change in NODS from baseline to FU is estimated in both CBT and SF condition, and a 95% confidence interval for the difference in change, i.e., ΔCBT-ΔSF, is calculated. The null-hypothesis of inferiority is rejected if the upper bound of this confidence interval is greater than the inferiority bound defined to be -2 NODS-scale points, i.e., SF leads to a change in NODS not more than 2 points less than CBT. The inferiority bound was decided based on clinical experience from RCGD, judging how large a difference in NODS that is clinically visible.
Results will be analysed and reported according to the CONSORT statement. A statistician is continuously involved in the project.
158 studies on the registry are indexed under Gambling; 42 are open to participants now.
This study's planned enrollment of 150 is above the median of 66 across 128 interventional studies indexed under Gambling.
Browse Gambling studies →Aarhus University Hospital is the lead sponsor of 298 studies on the registry; 80 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be included patients should:
Exclusion Criteria:
Patients are excluded from participation if they:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm receive internet-based cognitive behavioral therapy via the therapist-guided online treatment platform "SpilleFri"
Behavioral: Internet-based cognitive behavioral therapy
Participants in this arm receive traditional synchronous cognitive behavioral therapy, face-to-face or via video-connection
Behavioral: Synchronous cognitive behavioral therapy
The internet-based CBT treatment arm is delivered via the online treatment platform "SpilleFri" and consists of nine internet-delivered modules delivered over 10-12 weeks. Modules contain written assignments and multiple-choice lists, combined with psychoeducation delivered in text, illustrations, and videos. The treatment is assisted by a therapist. The therapist contact is primarily written and takes place in an embedded secured message system on the platform. Participants can use the written message function whenever they want, and the therapist will respond on a specific day each week. Further, participants are offered up to three sessions of face-to-face or video-based therapist support during the treatment, depending on their preference. Treatment is regarded as completed if the participant has worked actively (logged in to the module and filled in at least one interactive exercise) in the first 6 modules of the treatment program.
Also known as: SpilleFri
In the sCBT condition, participants receive 9 individual sessions spread over 14-20 weeks, in a 1 to 1 format with a therapist, delivered either face-to-face or via video connection, depending on the participant's preference (there may be a mix). Treatment sessions take place weekly at the start of the course. After week 4, the aim is to have sessions at least every other week to maintain continuity in treatment. Further, participants are offered up to three additional sessions that can be included on request of participant or when therapists deem it necessary. Treatment is regarded as completed if the participant has attended 6 sessions of the treatment program.
Also known as: Face-to-face CBT
Change in Gambling Problems Past Month as Assessed by The National Opinion Research Center DSM Screen for Gambling Problems (NODS)
Measured by Danish translation of The National Opinion Research Center Screen for Gambling Problems (NODS). 17 items with a minimum score of 0 and a maximum score of 10, with higher scores meaning more servere gambling problems. Self-report measure collected through a web-based questionnaire program. For the purpose of the study, the NODS is modified to assess the last month instead of the last year.
Time frame: Baseline, 12 weeks/18 weeks (post treatment SpilleFri/sCBT), 24 weeks/30 weeks (3 month FU SpilleFri/sCBT), 64 weeks/70 weeks (12 month FU SpilleFri/sCBT)
Change in Gambling Symptoms past week as Assessed by Gambling Symptom Assessment Scale (G-SAS)
The Gambling-Symptom Assessment Scale (G-SAS) is a 12-item self-rated measure that is designed to assess gambling symptom severity and change during treatment. Each item is scored on a 4-point scale from 0-4 with 0 meaning no symptoms and 4 meaning extreme symptoms. The total maximum score is 48.
Time frame: Baseline, during treatment (weeks 4, 7, 10), post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70)
Change in Self-reported Gambling Net Loss past week as assessed by a single item
Estimated net loss past week. Single-item self-report measure collected through a web-based questionnaire program.
Time frame: Baseline, during treatment (weeks 4, 7, 10), post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70)
Overall health improvement
Measured by the 5-point clinical global improvement scale (CGI). The CGI is measured by self-report (CGI_p) and by clinician rating (CGI_c). 1 item assessing overall improvement or worsening on a 5-point scale with a maximum score of 5 and a minimum score of 1, with higher scores meaning a better outcome. Self-report measure collected throguh a web-based questionnaire program.
Time frame: Post (week 12/18, clinician rating), 3 month FU (week 24/30, participant and clinician rating)
Change in Symptoms of anxiety, depression, and psychological distress as Assessed by th SCL-90
Measured by 13 relevant subscores of the 92-item Danish version of the Symptom Checklist (SCL-92). All items are rated on 5point scales. Maximum and minimum scores for the items are respectively 20 and 4 for anxiety, 30 and 6 for depression, and 40 and 8 for general distress, with higher scores meaning worse outcomes, i.e. more symptoms. Self-report collected through a web-based questionnaire program.
Time frame: Baseline, post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70)
Change in Overall Quality of Life and General Health Satisfaction as Assessed by the WHOQoL
Overall quality of life and general health satisfaction is measured using two single-item subscales from the WHOQoL. Both items are scored on five-point Likert-scales with 1 indicating very poor quality of life/very low general health satisfaction, and 5 indicating best possible quality of life/health satisfaction.
Time frame: Baseline, post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70)
Change in Quality of Current Romantic Relationship as Assessed by the DAS-4
For participants who indicate that they are in a committed romantic relationship at baseline, the Dyadic Adjustment Scale, Brief Version (DAS-4) is used to measure the quality of the current relationship.The DAS-4 consists of four items with a maximum score of 21, indicating a very high relationship quality, and a minimum score of 0.
Time frame: Baseline, post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70)
Participant treatment expectancy and satisfaction as Assessed by the Experienced Treatment Credibility and Expectancy
Measured by the credibility/expectancy questionnaire. 6 items rated on a 1-9 or a 0%-100% scale, depending upon the item. The scale yields a mean expectancy/satisfaction score, ranging from maximum 100 % to minimum 0 %, with higher scores meaning higher expectancy of/satisfaction with the treatment. Self- report collected through a web-based questionnaire program
Time frame: Baseline and post (week 12/18)
Gambling Motives as Assessed by the Gambling Motives Questionnaire-Financial (GMQ-F)
Measured by the Gambling Motives Questionnaire-Financial (GMQ-F). The scale is condensed by selecting the two items with the highest factor loadings from each subscale, resulting in a total of 8 items. The scale assesses four primary motives for gambling: coping, enhancement, social, and financial. Each gambling motive has a maximum score of 8 and a minimum score of 2, with higher scores meaning higher degree of endorsement of the motive. Respondents are categorized based on their primary gambling motives, i.e. the gambling motive that is rated with the highest score. Self-report measure collected through a web-based questionnaire program.
Time frame: Baseline
Gambling pathway subtype as Assessed by the Gambling Pathways Questionnaire, GPQ
Measured by the Gambling Pathways Questionnaire (GPQ). 48 items with a maximum score of 288 and a minimum score of 48. The scale assesses etiological risk factors for problem gambling and categorizes respondents into one of three etiological subtypes, based on which of the following categories are scored the highest: Behaviorally Conditioned, Emotionally Vulnerable, and Antisocial-Impulsive. Self-report measure collected through a web-based questionnaire program
Time frame: Baseline
Change in Maladaptive Gambling Cognitions as Assessed by the Gambling-Related Cognitions Scale
To measure maladaptive gambling cognitions and gambling related self-efficacy, a shortened version of the Gambling-Related Cognitions Scale (GRCS; Raylu \& Oei, 2004) is used. The scale is condensed by selecting the two items with the highest factor loadings from each subscale, resulting in a total of 10 items. On each of the five subscales, maximum scores of 14 indicate servere maladaptive cognitions, and minimum scores of 2 indicate no maladaptive cognitions.
Time frame: Baseline, during treatment (weeks 4, 7, 10), post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70)
Change in Difficulties in Emotion Regulation as Assessed by the DERS-16
To measure difficulties in emotion regulation, the Difficulties in Emotion Regulation Scale (DERS-16) is used. The DERS-16 consists of 16 five-point Likert-scale items, with maximum scores of 80 indicating servere difficulties and minimum scores of 16 indicating no difficulties.
Time frame: Baseline, during treatment (weeks 4, 7, 10), post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70)
Participant activity in treatment program: Number of logins
Collected through logged data from the treatment program "SpilleFri"
Time frame: Collected during treatment (week 1 to week 12/18)
Contact with therapist per patient
Collected through therapist report in web-based questionnaire and logged data from the treatment program "SpilleFri".
Time frame: Therapist report collected at post (week 12/18). Logged data collected during treatment (week 1 to week 12/18)
Participant activity in treatment program: Time of the day of logins
Collected through logged data from the treatment program "SpilleFri"
Time frame: Collected during treatment (week 1 to week 12/18)
Participant activity in treatment program: Number of messages written to and received from therapists
Collected through logged data from the treatment program "SpilleFri"
Time frame: Collected during treatment (week 1 to week 12/18)
Participant activity in treatment program: Textual content written in exercises and messages
Collected through logged data from the treatment program "SpilleFri"
Time frame: Collected during treatment (week 1 to week 12/18)
Participant activity in treatment program: Total time spent in the program, on each module, on each page
Collected through logged data from the treatment program "SpilleFri"
Time frame: Collected during treatment (week 1 to week 12/18)
Plan to share: No — To protect participant anonymity, individual participant data (IPD) will not be shared. Instead, aggregate data will be shared in an anonymized form.
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Jan 2027, 23 months after the start.
Of 47 non-industry interventional studies with no phase under Gambling, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 51. This study's planned 23 months is above that.
Counting every sponsor, half of 47 studies reached it within 16 months; a quarter within 10 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.